Risk Of Worse Outcomes Research Articles

Clinical, Laboratory and Radiographic Features Associated With Prolonged Hospitalization in Children With Complicated Appendicitis.

ObjectiveIn children with appendicitis, rupture of the appendix is associated with a significant increase in morbidity. We sought to characterize the spectrum of illness in children with complicated appendicitis and to define those factors associated with a longer hospital stay.Study DesignWe conducted a retrospective review of 132 children, 18 years of age or younger at a large urban teaching hospital in the Bronx, NY between October 2015 and April 2018 with an intraoperative diagnosis of perforated appendix. Clinical, laboratory and radiologic findings were reviewed, and the primary study outcome was length of stay (LOS) dichotomized at the median, which was 7 days. Statistical analyses were done to characterize morbidity and define variables predictive of longer stay.ResultsChildren in the longer LOS group experienced significantly more morbidity, including ICU stay, ileus, and need for multiple drainage procedures. A longer duration of symptoms prior to presentation was associated with a longer stay. Multivariable logistic regression analysis indicated that the presence of abscess and presence of free fluid in the right upper quadrant (RUQ FF) on initial imaging and C-reactive protein (CRP) level >12 at admission, were independently associated with a longer stay.ConclusionThere is considerable variation in the morbidity of complicated appendicitis. The association between longer stay and the findings of abscess and RUQ FF on initial imaging along with an elevated CRP may provide a useful tool in identifying those children at risk for worse outcomes.

The Impact of Socioeconomic, Racial, and Ethnic Disparities on Pulmonary Hypertension Diagnosis and Treatment

Health disparities have a major impact in the quality of life and level of clinical care received in minority populations in the United States. Underrepresented patients with pulmonary arterial hypertension (PAH) may be at risk for worse outcomes. Furthermore, advances in biomedical research have provided extensive knowledge on the genetic role in the pathogenesis of PAH but whether these also impact minorities is incompletely understood. Health disparities in patients with PAH create an enormous barrier in health care delivery. Understanding the contributors to health disparity represent a fundamental step towards personalized medicine and further improvement in PAH care.

Update on Association of Fried's Frailty Score and Sarcopenia After Left Ventricular Assist Device Implantation

<h3>Purpose</h3> While Fried's Frailty Assessment (FFA) is well-validated, it does include subjective components in its frailty assessment. The assessment of skeletal muscle density has recently emerged as an objective biomarker for frailty in patients with left ventricular assist device (LVAD) placement. The additive value of sarcopenia to existing frailty assessments and its association with outcomes in patients undergoing LVAD implantation requires further clarification. <h3>Methods</h3> We evaluated 43 patients who underwent LVAD implantation at our medical center between January 2018 and July 2021. Perioperative FFA score ≥ 3 was defined as frail. Skeletal muscle indexes were measured using preoperative computed tomography imaging of the psoas and pectoralis muscles areas. Sarcopenia was defined per the lowest skeletal muscle tertile with total psoas area index ≤4.45 or pectoralis muscle index ≤4.50. All time to event analysis excluded patients who died during their admission for LVAD. <h3>Results</h3> Of the 43 patients who had LVAD placement, eight patients met criteria for frailty based on FFA. When combined with frailty based on sarcopenia, 13 additional patients met criteria. The frail group had significantly lower albumin (3.33 vs. 3.78, p=0.046). There were no differences in age (54.1 vs 53.6 years, p=0.54) or BMI (27.6 vs. 31.1, p=0.15) between the frail and non-frail groups. Although the frail group had a greater proportion of patients with major bleed after discharge (38.1% vs. 13.6%), there was no significant difference in days to major bleed between both groups (log-rank p=0.112). The frail group had significantly higher rates of composite outcome of 30-day readmission and all-cause mortality (log-rank p=0.042), (Figure 1). <h3>Conclusion</h3> While FFA is a commonly used tool with subjective components for assessing frailty in patients with heart failure, the addition of objective sarcopenia biomarkers identifies additional patients with frailty, who are at risk for worse outcomes.

Unvaccinated Non-Elderly Adult Population Hospitalized for COVID-19: Risk for Severe Disease and Poor Outcomes.

Introduction:Vaccination offers significant protection against hospitalization and death due to severe COVID-19. However, a significant portion of the nonelderly U.S. adult population remains unvaccinated.Methods:This retrospective analysis of adult patients aged under 65 years hospitalized with PCR-confirmed SARS-CoV-2 between March and November 2021 assessed the age-biased risk for severe disease and outcome in non-elderly unvaccinated adults hospitalized for COVID-19. Main measures included predisposing risk factors, disease severity and progression, and outcomes in non-elderly adults compared between (1) vaccinated and unvaccinated individuals and (2) unvaccinated individuals grouped by 10-year age increment.Results:Two hundred nineteen non-elderly adults were included; of whom, 82.6% were unvaccinated. Overall, unvaccinated patients were more likely to be obese (60% vs 29%, P < .001) while vaccinated patients were more likely to have cardiovascular disease (50% vs 29%, P = .03). Unvaccinated individuals had prolonged ICU stay (11 vs 2 days, P = .002) and overall length of stay (6 vs 5 days, P < .0001), and higher proportion requiring oxygen at discharge (54% vs 29%, P < .0001). An age-stratified analysis of the unvaccinated cohort found that the time to discharge increased with age (P = .003). Compared to unvaccinated patients aged <46 years, unvaccinated patients aged ≥46 years demonstrated 1.47- and 3.49-times higher likelihood of oxygen dependency upon discharge (P = .002) and requiring higher level of care or worse at discharge (P = .004), respectively.Conclusion:Results from our non-elderly cohort affirm the benefit of vaccination despite a subset requiring hospitalization for breakthrough infection. In unvaccinated non-elderly adults, risk for worse outcomes and severe disease increased substantially from middle age onward and provides strong support for vaccination efforts in this population.

Андрологические аспекты новой коронавирусной инфекции COVID-19

COVID-19 is a new highly contagious infectious disease caused by the SARS-CoV-2. The World Health Organization (WHO) on March 11, 2020, has declared the novel coronavirus (COVID-19) outbreak a global pandemic. More attention is currently paid to the fact that men are more at risk for worse outcomes. In addition, SARS-CoV-2 can infect the testes, potentially affecting testosterone production, as well as having a negative influence on the reproductive potential. Our aim was to review the current concepts of the possible influence of testosterone levels on the pathogenesis of COVID-19 in men and to present the available data on the impact of COVID-19 on the structure and function of the testis. Based on the analysis of 72 articles using the MEDLINE database (PubMed), it can be concluded that testosterone is involved in the co-regulation of the synthesis of angiotensin-converting enzyme-2 and transmembrane serine protease-2, facilitating the penetration of SARS-CoV-2 into target cells and promoting easier infection in men. On the other hand, low testosterone levels increase the risk of cardiopulmonary complications. Hypogonadism appears to be an important unfavorable prognostic factor for the disease. Orchitis is a reported complication of COVID-19. Damage to testicular tissue is possible due to direct invasion by a virus, a secondary autoimmune reaction, hyperthermia and thrombosis of testicular microvessels. Prophylaxis of possible vertical and sexual transmission of infection is recommended. Despite the available data, further studies are required to assess the definite role of androgens in the course of infection and the influence of SARS-CoV-2 on male reproductive potential.

A Genome-Wide Association Study of Severe Asthma Exacerbations in Latino Children and Adolescents

Asthma is the most common chronic respiratory disease among children, and, although, in genome-wide association studies, researchers have identified specific loci related to asthma, there is little known about genetic determinants of asthma exacerbations. Recent evidence suggests some susceptibility variants for asthma-related outcomes are ethnicity specific. The purpose of this study was to investigate the effect of these susceptibility variants in Latino subgroups by performing a meta-analysis of genome-wide association studies of severe asthma exacerbations among Hispanic youth with asthma.This meta-analysis involved 4 separate studies (Hartford Puerto Rico study, the Genetics of Asthma in Latino Americans study, the Genetics of Asthma in Costa Rica study, and the Social Change, Asthma and Allergy in Latin America study) with a population of 4010 Latino children (1693 Puerto Ricans, 1019 Costa Ricans, 640 Mexicans, 256 Brazilians, and 402 members from other Latino subgroups). A total of 2509 individuals with asthma and ≥1 severe asthma exacerbation were included as cases, and 1501 individuals with asthma but no severe asthma exacerbation were included as controls.Methylation quantitative trait locus, expression quantitative trait locus, and expression quantitative trait methylation analyses were conducted to assess if the top single-nucleotide polymorphism (SNP) identified in the meta-analysis was linked to DNA methylation and gene expression in airway epithelium.In this meta-analysis, researchers found 1 SNP (rs2253681) in the FLJ22447 locus on chromosome 14q23.2 that was significantly associated with severe asthma exacerbations (P < 5 × 10−8). Each copy of the minor allele of SNP rs2253681 was associated with 1.55 times increased odds of severe asthma exacerbations (95% confidence interval: 1.34 to 1.79; P = 6.3 × 10−9).SNP rs2253681 was found to be significantly associated with severe asthma exacerbations in Latino children and adolescents with asthma.This study reveals the potential utility of genomics in the counseling and management of asthma. As more genetic mutations associated with asthma and asthma outcomes are identified, the better we can understand genetic components of this disease and can develop targeted therapies on the basis of gene-specific changes. Further genomic studies are needed to identify mutations associated with airway function and severe asthma exacerbations to identify those at risk for worse outcomes and those who may respond better to certain therapies on the basis of genetics.

Disease characteristics and mortality among Asian women with breast cancer.

Asian women with breast cancer are often studied in aggregate, belying significant intragroup diversity. The authors sought to examine differences in breast cancer characteristics and outcomes among Asian women. Asian, non-Hispanic Black, Hispanic, and non-Hispanic White women aged 18 years and older who were diagnosed with breast cancer from 1990 to 2016 were identified in the Surveillance, Epidemiology, and End Results 18 database. Asian patients were subclassified as Chinese, Japanese, Korean, Filipino, Vietnamese, South Asian (Asian Indian or Pakistani), Southeast Asian (SEA, i.e., Cambodian, Laotian, Hmong, or Thai), or other Asian. Unadjusted overall survival (OS) and cancer-specific survival (CSS) were estimated using the Kaplan-Meier method. Cox proportional hazards models were used to estimate adjusted OS and CSS. In total, 910,415 women were included (Asian, n = 63,405; Black, n = 92,226; Hispanic, n = 84,451; White, n = 670,333). Asian women had higher rates of human epidermal growth factor receptor 2 (HER2)-positive disease compared with White women (18.7% vs 13.8%) and had the highest 10-year unadjusted OS and CSS among all racial/ethnic groups (all P < .001). SEA women had the highest rates of stage IV disease at presentation, whereas Japanese women had the lowest rates (5.9% vs 2.7%; P < .001). Japanese women had the highest 10-year unadjusted CSS (89.4%; 95% confidence interval, 88.7%-90.1%) of any distinct Asian group, whereas SEA women had the worst unadjusted CSS (78%; 95% confidence interval, 74.1%-81.3%; P < .001). After adjustment, SEA women had the worst OS of any Asian group and were the only Asian group without improved OS compared with White women (reference category; P = .08). Breast cancer characteristics and outcomes vary significantly among Asian women. Future research should consider disaggregation by country or region of origin to identify subgroups that are at risk for worse outcomes than aggregated data may suggest. Asian women with breast cancer are frequently studied as a single entity. However, Asian ethnic groups differ greatly by country of origin, genetic ancestry, disease frequency, socioeconomic status, patterns of immigration, as well as dietary and cultural practices. Women of different Asian ethnicities vary significantly with regard to cancer characteristics, such as mortality and tumor subtype. Future research should disaggregate these populations to better understand, treat, and counsel Asian patients with breast cancer.

Chronic heart failure in intensive care unit: can we accurately predict the risk?

Abstract Background Severity of disease scoring systems, namely the Simplified Acute Physiology Score (SAPS) and Acute Physiology and Chronic Health Evaluation (APACHE), are widely used to predict mortality in Intensive Care Units (ICU). Yet, neither score includes chronic HF in their model. We aimed to evaluate whether these scores perform well in risk prediction of death of patients previously diagnosed with heart failure (HF). Methodology This is a single-center retrospective cohort of patients admitted to an ICU in 2019. Those whose admission lasted &amp;lt;24 hours were excluded from analysis. The SAPS II and APACHE II scores were calculated using data from the first 24 hours of ICU admission, imputing the worst variable obtained within this timeframe. HF was defined according to the ESC recommendations. In order to assess the performance of the scores, Receiver Operating Characteristic (ROC) Curves were used to predict the risk of death in ICU in HF compared to the non-HF population. Results A total of 267 patients were hospitalized in ICU for a period over 24 hours in 2019 (mean age 67±16 years; 58.8% males; 21.7% with chronic HF; 33.7% admitted for sepsis). Compared to patients without HF, those with chronic HF were older (74±13 vs. 65±16 years; p&amp;lt;0.001) and had higher risk scores (mean SAPS II: 43.2±21.7 vs. 56.5±20.7; p&amp;lt;0.001; mean APACHE II: 19.8±10.0 vs. 25.1±10.0; p&amp;lt;0.001). Moreover, these patients were at higher risk of meaningful events during hospitalization (e.g. acute kidney injury: 38.0 vs. 66.1%; p&amp;lt;0.001; shock at any time: 52.4 vs. 67.8%; p=0.036). Furthermore, patients with HF had a trend towards higher mortality rates in ICU (17.3 vs. 28.8%; p=0.051) and a significantly higher death in overall hospitalization (30.8 vs. 45.8%; p=0.032). ROC curves performed well in predicting the risk of ICU death regardless of HF (SAPS II – AUC 0.78 vs. 0.81; p=0.36; APACHE II – AUC 0.75 vs. 0.78; p=0.37). Conclusion Approximately 1 in every 4 patients admitted to the ICU had chronic HF. Traditional risk scoring systems (SAPS II and APACHE II) performed well regardless of HF. While these results are reassuring as far as risk stratification accuracy is concerned, HF patients remained at a higher risk for worse outcomes. Therefore, prognostic tools with a therapeutic clinical applicability are urgently needed to improve the outcome of this population. Funding Acknowledgement Type of funding sources: None.

Discharge FGF23 levels predicts one year outcome in patients admitted with acute heart failure

Abstract Background Patients with acute heart failure (AHF) show high levels of fibroblast growth factor-23 (FGF23) on admission. We examined if plasma FGF23 changes during an episode of AHF, and if FGF23 holds prognostic significance in this setting. Methods Consecutive AHF patients were enrolled. Blood samples were collected on admission and at discharge. Patients were then followed for all-cause death or HF hospitalization. Results Patients (n=125; median age 76 years [interquartile interval 71–83], 63% men, left ventricular ejection fraction 35% [25–56%]) had median admission FGF23 70 ng/L (47–100), N-terminal pro-B-type natriuretic peptide (NT-proBNP) 5,844 ng/L (2,503–10,468), high-sensitivity troponin T (hs-TnT) 40 ng/L (25–72), and soluble suppression of tumorigenesis-2 (sST2) 26 ng/mL (17–37). While other biomarkers decreased, FGF23 increased by 15% from admission to discharge (p=0.033), with a significant correlation with percent changes in estimated glomerular filtration rate (rho=0.306, p=0.001). Over a 12-month follow-up, 64 patients (51%) experienced the endpoint. They were more often men, older, with higher systolic pulmonary artery pressure (sPAP), higher NT-proBNP, hs-TnT and discharge FGF23. The best FGF23 cut-off at discharge from receiver operating characteristics analysis was 78 ng/L. Both discharge FGF23 and the 78 ng/L cut-off independently predicted outcome in models including gender, sPAP, age, and 1) admission NT-proBNP, 2) discharge NT-proBNP, 3) admission NT-proBNP and hs-TnT, 4) discharge NT-proBNP and hs-TnT. The 78 ng/L cut-off also refined risk reclassification. Conclusions During an AHF episode, FGF23 increases from admission to discharge, and patients with higher discharge FGF23 have a higher risk of worse outcome. Funding Acknowledgement Type of funding sources: None.

Psychological factors and trajectories of post-surgical pain: A longitudinal prospective study.

A significant proportion of patients do not experience relief from pain during the early postsurgical period after joint arthroplasty and are at risk for developing chronic pain. The objectives of this study were to identify biopsychosocial factors associated with acute postsurgical pain trajectories and with pain intensity and interference after 1, 3, and 12 months. Two hundred ten patients listed for joint arthroplasty filled a presurgical battery of questionnaires assessing presurgical pain intensity, catastrophizing, emotional distress, state anxiety and depression, self-efficacy, central sensitization, and executive functions. From the day after surgery, they were asked to fill a 7-day diary, including questions about postsurgical pain and postsurgical state catastrophizing. Finally, they provided data about pain intensity and interference after 1, 3, and 12 months. Predictors of acute pain trajectories were investigated using multilevel growth curve analysis. Results showed that central sensitization was a predictor of the intercept of pain trajectories and daily postsurgical catastrophizing was a significant covariate of pain intensity in the acute phase. Analyses of follow-up data showed that central sensitization was a predictor of pain intensity and pain interference at 3 and 12 months, that emotional distress was related with pain intensity and interference at 1 month, and with pain interference at 3 months, and that cognitive flexibility was associated with pain interference at 1 month. Assessment of these factors could enable to identify patients at risk for worse outcomes and to plan targeted treatments to be implemented during the patient's inward stay.

Basic mechanisms of SARS-CoV-2 infection. What endocrine systems could be implicated?

Although SARS-CoV-2 viral attacks starts by the interaction of spike protein (S Protein) to ACE2 receptor located at the cell surface of respiratory tract and digestive system cells, different endocrine targets, endocrine organs and metabolic conditions are of fundamental relevance for understanding disease progression and special outcomes, in particular those of fatal consequences for the patient. During pandemic, moreover, a specific phenotype of COVID-19 metabolic patient has been described, characterized by being at particular risk of worse outcomes. In the present paper we describe the mechanism of viral interaction with endocrine organs, emphasizing the specific endocrine molecules of particular relevance explaining COVID-19 disease evolution and outcomes.

COVID-19 patients with obesity at risk for worse outcomes despite younger age and fewer inflammatory derangements.

BackgroundCoronavirus disease 2019 (COVID-19) is a viral pulmonary infection that can progress to cytokine storm syndrome because of widespread dysregulated inflammatory response. Many patients at risk for severe COVID-19 manifestation have been identified as those with preexisting conditions of pulmonary origin, as well as conditions that impair appropriate immune response, such as obesity.ObjectivesThe aim of this study is to describe the manifestation, clinical course, and inflammatory biomarker milieu of COVID-19 in patients with obesity.SettingUniversity Hospital Philadelphia, Pennsylvania.MethodsIn this retrospective cohort study, 600 patients who were positive for COVID-19 were stratified by World Health Organization (WHO) obesity class and their presenting symptoms, disease biomarkers, demographics, and outcomes (intubation rate, intensive care unit [ICU] admission, length of stay [LOS], and mortality) were investigated.ResultsAge was inversely related to obesity class; patients of obesity class III presented 12.9 years younger than patients of normal weight (P < .0001). Initial ferritin lab values were negatively correlated with increasing obesity class (P = .0192). Normal or near-normal lymphocyte profile was noted in patients with obesity compared with patients without obesity (P = .0017). Patients with obesity had an increased rate of ICU admission (P = .0215) and increased length of stay (P = .0004), but no differences in intubation rate (P = .3705) or mortality (P = .2486).ConclusionPatients with obesity were more likely to present to the hospital at a younger age, with reduced levels of COVID-19 related biomarker disturbances, and increased LOS and ICU admission rates, although were not at increased risk for mortality.

Severe vision impairment and blindness in hospitalized patients: a retrospective nationwide study

BackgroundOutcomes among hospitalized patients with severe vision impairment or blindness have not been extensively explored. This study sought to determine clinical and resource utilization outcomes in patients with severe vision impairment/blindness (SVI/B). Because obesity is very common among those who are hospitalized, we also sought to understand its impact among patients with SVI/B.MethodsWe conducted a retrospective study using the National Inpatient Sample for the year 2017; hospitalized adults with and without SVI/B were compared. In addition, for all patients with SVI/B, we compared those with and without obesity. Multiple logistic regression and linear analysis were used to evaluate mortality, disposition, length of stay, and hospital charges; the analyses were adjusted for multiple variables including age, sex, and race.Results30,420,907 adults were hospitalized, of whom 37,200 had SVI/B. Patients with SVI/B were older (mean age ± SEM: 66.4 ± 0.24 vs. 57.9 ± 0.09 years, p < 0.01), less likely to be female (50 % vs. 57.7 %, p < 0.01), more frequently insured by Medicare (75.7 % vs. 49.2 %, p < 0.01), and had more comorbidities (Charlson comorbidity score ≥ 3: 53.2 % vs. 27.8 %, p < 0.01). Patients with SVI/B had a higher in-hospital mortality rate (3.9 % vs. 2.2 %; p < 0.01), and had lower odds to be discharged home after hospital discharge (adjusted Odds Ratio {aOR} =0.54, [Confidence Interval (CI) 0.51–0.58]; p < 0.01) compared to those without SVI/B. Hospital charges were not significantly different (adjusted Mean Difference {aMD} = $247 CI [-$2,474-2,929]; p = 0.85) but length of stay was longer (aMD = 0.5 days CI [0.3–0.7]; p < 0.01) for those with SVI/B. Patients with vision impariment who were also obese had higher total hospital charges compared to those without obesity (mean difference: $9,821 [CI $1,375-$18,268]; p = 0.02).ConclusionsPatients admitted to American hospitals in 2017 who had SVI/B had worse clinical outcomes and greater resources utilization than those without SVI/B. Hospital-based healthcare providers who understand that those with SVI/B may be at risk for worse outcomes may be optimally positioned to help them to receive the best possible care.

Outcome of COVID-19 in Patients With Autoimmune Hepatitis: An International Multicenter Study.

Background and AimsData regarding outcome of COVID‐19 in patients with autoimmune hepatitis (AIH) are lacking.Approach and ResultsWe performed a retrospective study on patients with AIH and COVID‐19 from 34 centers in Europe and the Americas. We analyzed factors associated with severe COVID‐19 outcomes, defined as the need for mechanical ventilation, intensive care admission, and/or death. The outcomes of patients with AIH were compared to a propensity score–matched cohort of patients without AIH but with chronic liver diseases (CLD) and COVID‐19. The frequency and clinical significance of new‐onset liver injury (alanine aminotransferase > 2 × the upper limit of normal) during COVID‐19 was also evaluated. We included 110 patients with AIH (80% female) with a median age of 49 (range, 18‐85) years at COVID‐19 diagnosis. New‐onset liver injury was observed in 37.1% (33/89) of the patients. Use of antivirals was associated with liver injury (P = 0.041; OR, 3.36; 95% CI, 1.05‐10.78), while continued immunosuppression during COVID‐19 was associated with a lower rate of liver injury (P = 0.009; OR, 0.26; 95% CI, 0.09‐0.71). The rates of severe COVID‐19 (15.5% versus 20.2%, P = 0.231) and all‐cause mortality (10% versus 11.5%, P = 0.852) were not different between AIH and non‐AIH CLD. Cirrhosis was an independent predictor of severe COVID‐19 in patients with AIH (P < 0.001; OR, 17.46; 95% CI, 4.22‐72.13). Continuation of immunosuppression or presence of liver injury during COVID‐19 was not associated with severe COVID‐19.ConclusionsThis international, multicenter study reveals that patients with AIH were not at risk for worse outcomes with COVID‐19 than other causes of CLD. Cirrhosis was the strongest predictor for severe COVID‐19 in patients with AIH. Maintenance of immunosuppression during COVID‐19 was not associated with increased risk for severe COVID‐19 but did lower the risk for new‐onset liver injury during COVID‐19.

DOP33 Predictors of ileo-rectal anastomosis, permanent ileostomy and recurrence of disease after total colectomy for Crohn’s Colitis: Results over 20 years

Abstract Background Patients with surgical Crohn’s colitis (CC) might either undergo a total colectomy (TC) and ileo-rectal anastomosis (IRA), or TC and end ileostomy. Among the latter group, a second-stage IRA is not always performed. The predictors of the different outcomes after TC (including the recurrence of disease at the level of the anastomosis) are yet to be identified. Methods Retrospective study including 354 patients undergoing TC for CC (2000–2019), with a minimum preoperative follow-up of 2 years in our centre. The mean postoperative follow-up was 67.5+/-49.8 months (62 patients lost). The primary end-points were to identify the predictors for the following outcomes: a) IRA (87 cases, 24.6%) vs. end ileostomy (267 cases, 75.4%) at the primary colectomy. b) second-stage IRA (80 cases, 39%) vs. no IRA (125 cases, 61%) at the last follow-up. c) recurrence of the disease after IRA (167 patients). Considering the large number of regressors and the risk of over-fitting, the least absolute shrinkage and selection operator (LASSO) method was used. A multivariate analysis was carried out using the preselected covariates. The analysis was conducted using logistic regression and cox regression for dichotomus and time-dependent outcomes. A p-value&amp;lt;0.05 was considered significant. Results a) Predictors against the IRA at primary TC: preoperative biologic exposure (OR=1.96, CI 1.15–3.33, p=0.014), Crohn’s rectal location (OR=4.17, CI 2.0–8.33, p&amp;lt;0.0001), perianal disease (OR=3.33, CI 1.75–6.25, p&amp;lt;0.0001), and low hemoglobin concentration (OR=1.26, CI 1.01–1.58, p=0.037). b) Predictors of the risk of still having the ileostomy at the follow-up: age (OR: 1.02, CI 1.00–1.04, p=0.045), exposure to biologics before (OR 1.85, CI 1.11–3.03, p=0.017) and after (OR 1.79, CI 1.11–2.89, p=0.018) the TC; postoperative use of azathioprine was associated with a greater chance of a second-stage IRA (OR 2.66, CI 1.21–5.83, p=0.014). c) Risk of anastomotic recurrence was 8.7% and 30.8% at 5 and 10 years. Significant predictors were: female gender (OR 2.38, CI 1.11–5.55, p=0.046), use of more than one biologic (OR 5.65, CI 2.18–9.89, p&amp;lt;0.0001) and worsening of symptoms needing for drug escalation (OR 5.51, CI 2.06–8.59, p=0.001) during the follow-up. Conclusion The location and severity of the disease at diagnosis predict the long-term behavior of the disease. The exposure to biologics, especially if multiple drugs are required, does not represent a risk for worse outcomes per se, but rather identifies a population at higher risk of permanent ileostomy due to more severe disease. These predictors might be implemented in the assessment of patients affected by CC, in order to identify the population at risk of permanent ileostomy.

Effects of Adjuvant Endocrine Therapy Adherence and Radiation on Recurrence and Survival Among Older Women with Early-Stage Breast Cancer.

The Cancer and Leukemia Group-B 9343 (CALGB 9343) trial demonstrated that women aged ≥ 70 years with early-stage breast cancer can safely omit radiation therapy (RT) and be treated with breast-conserving surgery (BCS) and adjuvant endocrine therapy (AET) alone. AET adherence is low, leaving an undertreated cohort who may be at increased risk of recurrence and death. We hypothesized that AET adherence and adjuvant treatment choice impact recurrence and survival among CALGB 9343 eligible women. SEER-Medicare was used to identify CALGB 9343 eligible women who underwent BCS between 2007 and 2016. Medicare claims were used to identify AET use, and the proportion of days covered by AET was used to categorize adherent (PDC ≥ 0.80) versus nonadherent patients (PDC < 0.80). Recurrence-free, cancer-specific, and overall survival were assessed using Cox proportional hazards models. In total, 10,719 women were identified, of whom 780 (7.3%) underwent BCS alone, 1490 (13.9%) underwent BCS + RT, 1663 (15.5%) underwent BCS + AET, and 6786 (63.3%) had BCS + RT + AET. Among women treated with BCS + AET, adherent patients had lower recurrence than did nonadherent patients (HR = 0.65, 95% CI: 0.50-0.85). With respect to adjuvant treatment combinations, there was no recurrence difference between the BCS + RT + AET group and BCS + AET group (HR = 0.81, 95% CI: 0.54-1.21). There was equivalent cancer-specific but worse overall survival in the BCS + AET group versus the BCS + AET + RT group. While BCS + RT + AET may represent overtreatment for some, AET nonadherent women who omit RT are at risk for worse outcomes. Treatment decisions regarding RT omission should be tailored to the individual patient, taking into consideration the chances of AET nonadherence and the patients' own risk tolerance.

Abstract S01-02: Assessing vulnerability of patients with lung cancer to SARS-CoV-2 infection based on serological antibody analyses

Abstract COVID-19 presents a unique threat to patients with lung cancer, with mortality rates as high as ~32%. Given the convergence of these two deadly diseases, the lung cancer research and advocacy communities rapidly mobilized in early 2020 to create the COVID Lung Cancer Consortium (CLCC), a global assembly of leading experts in thoracic oncology, immunology, virology, vaccines and patient advocacy. With ongoing robust exchange of data and shared learning and rational planning for clinical and laboratory investigations, the CLCC is bringing its collective expertise to bear on beginning to address the question of why patients with lung cancer are at such elevated risk of worse outcomes from COVID-19. These efforts led to a recently funded U54 CA260560 grant as part of the National Cancer Institute’s SeroNet initiative to study the magnitude, quality and duration of antibody responses to SARS-CoV-2 infection in patients with lung cancer compared to healthy controls. In the first project, our Mt. Sinai U54 Serological Center of Excellence will follow a prospective lung cancer cohort (750 patients) and a matched non-lung cancer control group (750 individuals) to determine if there are differences in antibody responses related to age, gender, tobacco history, and race/ethnicity. Given that effective SARS-CoV-2 vaccines are now being deployed, the study will also analyze antibody responses to vaccination across these two patient cohorts. The second project will examine biological determinants correlating with susceptibility to infection, including analysis of both ACE2 and TMPRSS2 levels, and antibody-mediated neutralization in pre-clinical models of established lung cancer and normal lung epithelial cell lines. In order to capture a diverse and inclusive patient population, this effort will be supported by GO2 Foundation for Lung Cancer through its national network of Centers of Excellence. This rapid global mobilization of the lung cancer community through the CLCC and the resulting Serological Center of Excellence is positioned to answer fundamental questions regarding the susceptibility of patients with lung cancer to SARS-CoV-2 infection and severe COVID-19 disease and provide information to allow assessment of the value of vaccination and the utility of specifically designed vaccine programs for this high-risk patient population. Citation Format: Amy C. Moore, Paul A Bunn Jr., Beatriz Fontoura, Adolfo García-Sastre, Jorge Gomez, Florian Krammer, Phillip Mack, John D. Minna, Christian Rolfo, Yu Shyr, Peter Ujhazy, Fred R. Hirsch. Assessing vulnerability of patients with lung cancer to SARS-CoV-2 infection based on serological antibody analyses [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr S01-02.

Elucidating SARS-CoV-2 Infection in Pregnant Women

Pregnant women with COVID-19 are at risk for worse outcomes than nonpregnant women. To better understand the interaction between pregnancy, the fetus,

Kardiovaskularne bolesti i komplikacije u COVID-19

From the late fall of 2019 until the beginning of 2020, SARS-CoV-2 infection is becoming the biggest global challenge of health systems worldwide. Characteristic of the encounter with the disease caused by COVID-19 was a certain wandering in the mechanisms of action of the virus, its consequences, and thus in therapy. Various manifestations of the disease confirm the assumption that it is a systemic infection with the respiratory system as an entry route. We were also faced with the fact that the SARS-CoV-2 virus has great implications for the cardiovascular system. Patients with cardiovascular risk factors, including male gender, advanced age, diabetes, hypertension, and obesity, as well as patients with established cardiovascular and cerebrovascular disease, have been identified as particularly susceptible populations with increased morbidity and mortality from COVID-19. The effects on the cardiovascular system are reminiscent of other diseases caused by this group of viruses. There are biochemical, electrocardiographic and echocardiographic confirmations of functional disorders. It is basically an immune response caused by tissue inflammation, which results in prothrombogenicity as the dominant and biggest problem, coupled with the highest risk of a possible bad outcome. Being a systemic disease with numerous and different repercussions on the cardiovascular system, COVID-19 can lead to the appearance of all cardiovascular diseases that the patient did not have before, or to a significant worsening of the existing cardiovascular disease. The condition after the disease in most cases also means recovery, but great caution is needed due to possible time-distant complications. Since there is a high risk of death in the end, it is necessary to apply all available measures, especially in the field of prevention of thromboembolic complications, as a factor of the greatest risk of a bad outcome.

Association between ROTEM Hypercoagulable Profile and Outcome in a Cohort of Severely Ill COVID-19 Patients Under Mechanical Ventilation

Introduction: Recently published data show that COVID-19 is characterized by a hypercoagulable ROTEM profile and decreased fibrinolysis. Multiple reports suggest that severe COVID-19 infection is associated with an increased thromboembolic risk. There are limited data associating a hypercoagulable ROTEM profile and outcomes in the literature. A hypercoagulable ROTEM profile could help identify patients at risk of worse outcome and help target a study population for enhanced anticoagulation therapy or other COVID-19 therapy.Objectives: To determine if early hypercoagulability on ROTEM is associated with a higher risk of thromboembolic complications or worse outcome, in a population of mechanically ventilated COVID-19 patients transferred to a tertiary ARDS/ECMO referral center.Methods: All COVID-19 patients receiving mechanical ventilation at our center between April 3 and June 15, 2020 were assessed with ROTEM. Testing performed included at least ExTEM and FibTEM. Patients were classified as hypercoagulable (HC) or not (nHC) using the following criteria from ROTEM: ExTEM clot formation time (E_CFT)< 40 sec, alpha (∝) angle >79° and, either ExTEM or FibTEM maximum clot firmness (E_MCF or F_MCF) >70mm or >24mm, respectively. Outcomes, assessed at discharge from our ICU, included thromboembolic events (TE: composite of deep vein thrombosis, pulmonary embolism and ischemic stroke), acute kidney injury (AKI: AKIN stage >2 with or without dialysis), duration of mechanical ventilation, requirement for ECMO, and death. Difference between groups was determined using the chi-square or Fisher-exact test for categorical data and a t-test for continuous variables respectively, using p<0.05 as significant.Results: Of 59 patients included, 31 were hypercoagulable (HC) on admission. Mean (SD) age was 52 (14), and SOFA score on admission was high 15 (2). The severity of disease was similar in both groups especially for the cardiac and respiratory SOFA components (Table 1). The composite outcome of TE was not different between the groups (HC 9/31, nHC 6/28, p=0.7). The composite renal outcome was not different (HC 18/31 vs nHC 16/28). Mortality rate (29%, HC 9 vs nHC 8), and the duration of ventilation in survivors (HC 22 vs nHC 22 days) were similar in both groups. Requirement for ECMO support was similar (HC 8 vs nHC 12, p= 0.27). Patients were tested with daily viscoelastic tests and, neither fibrinolysis nor DIC were documented. All patients received TE prophylaxis and 34 received therapeutic intravenous heparin for ECMO (n=20) or TE treatment (n=14). Initial ROTEM were conducted on therapeutic heparin in 22 cases (12 HC, 10 nHC).Conclusion: Our data suggest that in a population of mechanically ventilated patients with severe COVID-19, an early hypercoagulable profile on ROTEM was not associated with an increased risk of thromboembolic events, AKI, prolonged ventilation, ECMO or death during their ICU stay.DisclosuresKarkouti:Octapharma: Research Funding; Canadian blood services: Research Funding.